Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives--where your purpose accelerates our mission.

Your Role at Baxter:

Baxter's Respiratory Health business unit products expand therapies to better help patients and

physicians to manage chronic or acute respiratory and cardiac diseases (COPD, CHF, etc.). The earlier the treatment for these patients - the better the quality of life. The $150M business portfolio includes products for airway clearance and ventilation.

The role of V&V Engineer II is to independently Verifying and Validating the device with minimal / no supervision. In addition to providing technical support and service in these areas, the incumbent may also perform the following functions: requisitioning, defining, initiating, specifying, documenting and training.

This position is based out of Bangalore and reporting to the V&V Manager for Respiratory Health division of Front Line Care.

Essential Duties and Responsibilities:

Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device: Which includes but not limited to:

Test Plans, Test Procedures, User and Functional Requirements testing,

Design Verification,

Installation/Operational/Performance Qualification Protocols,

Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.

Support the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.

Diagnose, isolate and investigate problem reports. Drive product improvements and/or bug fixes.

Works with external test houses (such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports.

Ensure good documentation and Good Manufacturing practices are followed in the Verification and Validation Process

Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives

Participate in V&V development process improvement and test automation.

Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.

Support the SMEs on Regulatory responses and Audits, as needed

Adheres to Baxter Quality Management system & supports the quality audits.

Presents the findings / objective evidences and able to present with rationale with applicability / exclusions

Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.

Your Team:

You will be reporting to V&V Manager for Respiratory Health. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions.

Your Location:

The role is located in the BRD facility in Bangalore India.

What You'll Bring:

Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field

3 to 6 years of experience in Verification and validation testing of Software, hardware and System.

Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing

An understanding of test methods and processes as well as the methods used to verify product in the realms of; software, mechanical, electrical, functional and environmental testing environments.

Experience in - writing system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation

Understanding of hardware and software product design methodologies and test practices.

Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability.

Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems

Deep domain knowledge in design verification and validation of medical devices is a plus

Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.

Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously

Self-motivated with good interpersonal skills

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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